Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

June 25, 2021 updated by: Methodist Health System
The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC). This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution. The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care. The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC. Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC). However, with new technical and physician expertise, this option is now available at our institution. PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Age 18 years or older and have undergone EUS-guided liver biopsy at MDMC

Description

Inclusion Criteria:

  • Age 18 years or older
  • Undergone EUS-guided liver biopsy at MDMC

Exclusion Criteria:

  • Below 18 years of age
  • Did not undergo EUS-guided liver biopsy at MDMC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Undergone EUS-guided liver biopsy at MDMC
Procedure: EUS-guided liver biopsy at MDMC
Endoscopic ultrasound (EUS) guided liver biopsy sampling is emerging as an alternative to the aforementioned approaches that offers several advantages, including decreased sampling variability and procedure-related complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of core biopsy
Time Frame: 9/1/2017 and 9/1/2019
9/1/2017 and 9/1/2019
Number of portal tracts
Time Frame: 9/1/2017 and 9/1/2019
9/1/2017 and 9/1/2019
Diagnostic yield
Time Frame: 9/1/2017 and 9/1/2019
We will define an adequate specimen as one containing ≥11 portal tracts or measuring ≥20 mm cumulative core length.
9/1/2017 and 9/1/2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2017

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 045.GID.2017.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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